Losartan Krka 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartán Krka 100 mg film-coated tablets EFG

losartan potassium

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could be harmful to them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Losartán Krka is and what it is used for
2. What you need to know before taking Losartán Krka
3. How to take Losartán Krka
4. Possible adverse effects
5. How to store Losartán Krka
6. Contents of the pack and other information

1. What Losartán Krka is and what it is used for

Losartan belongs to a group of medicines called angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Krka is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating kidney impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan.
• in patients with high blood pressure and thickening of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking Losartán Krka

Do not take Losartán Krka

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant (do not take Losartán Krka during the first 3 months either – see also "Pregnancy and breastfeeding"),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Losartán Krka.

If you are pregnant, think you may be pregnant (or are planning to become pregnant), you must inform your doctor. Losartán Krka is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn baby during this stage (see section Pregnancy and breastfeeding).

Before taking Losartán Krka, it is important that you inform your doctor:

• if you have a history of angioedema (swelling of the face, lips, tongue and/or throat) (see also section 4. Possible side effects),

• if you are experiencing excessive vomiting or diarrhoea, leading to excessive loss of fluid and/or salt from your body,

• if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may cause excessive loss of fluid or salt from your body (see section 3. Dosage in special patient groups),

• if you know you have narrowing or blockage of the blood vessels supplying your kidneys or if you have recently had a kidney transplant,

• if you have impaired liver function (see sections 2. Do not take Losartán Krka and 3. Dosage in special patient groups),

• if you have heart failure with or without kidney failure or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker,

• if you have heart valve problems or heart muscle disease,

• if you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain),

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to dysfunction of this gland),

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán Krka”),

• if you are taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Losartán Krka”.

Contact your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Children and adolescents

Losartan has been studied in children. For more information, consult your doctor.

Losartán Krka is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartán Krka is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Other medicines and Losartán Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics (e.g. amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g. heparin, medicines containing trimethoprim), as combination with Losartán Krka is not recommended.

While being treated with Losartán Krka, take particular care if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional decrease in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking ACE inhibitors or aliskiren (see also the information under the headings “Do not take Losartán Krka” and “Warnings and precautions”).

Taking Losartán Krka with food, drinks and alcohol

Losartán Krka can be taken with or without food.

Grapefruit juice should be avoided while taking Losartán Krka.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Normally, your doctor will advise you to stop taking Losartán Krka before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative treatment to Losartán Krka. Losartán Krka is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartán Krka is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed. This is especially important if your baby is a newborn or was born prematurely.

Driving and using machines

No studies on the ability to drive and use machines have been conducted.

It is unlikely that Losartán Krka will affect your ability to drive or use machines. However, like many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before carrying out such activities.

Losartán Krka contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Losartán Krka

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose of Losartán Krka depending on your condition and whether you are taking other medicines. It is important to continue taking Losartán Krka as prescribed by your doctor to maintain consistent blood pressure control.

Losartán Krka is available in strengths of 25 mg, 50 mg, and 100 mg.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one Losartán Krka 50 mg tablet) once daily. The maximum blood pressure-lowering effect is achieved within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two Losartán Krka 50 mg tablets or one Losartán Krka 100 mg tablet) once daily.

If you feel that the effect of Losartán Krka is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartán Krka is not recommended for use in children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Children aged 6–18 years

The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to 25 mg of Losartán Krka). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one Losartán Krka 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Losartán Krka 50 mg tablets or one Losartán Krka 100 mg tablet) once daily, depending on your blood pressure response.

Losartan tablets may be taken together with other blood pressure-lowering medicines (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally-acting agents), as well as with insulin and other commonly used glucose-lowering medicines (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is typically increased gradually on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, and 150 mg daily during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartán Krka 50 mg tablets, or one Losartán Krka 100 mg tablet plus one Losartán Krka 50 mg tablet) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of water passing through your kidneys) and/or digitalis (a medicine that helps your heart to become stronger and more efficient) and/or a beta-blocker.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartán Krka").

Administration

The tablets should be taken with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you continue taking Losartán Krka unless your doctor tells you otherwise.

If you take more Losartán Krka than you should

If you accidentally take too many tablets, or if a child swallows any, contact your doctor immediately. Symptoms of overdose may include low blood pressure, increased heart rate, and possibly decreased heart rate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Spanish Toxicology Information Service (Servicio de Información Toxicológica) at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Losartán Krka

Do not take a double dose to make up for missed doses.

If you accidentally miss a dose, simply take the next dose as usual.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following, stop taking losartan tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

A serious allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing).

This is a serious, although rare, adverse effect affecting more than 1 in 10,000 patients but less than 1 in 1,000 patients. Urgent medical attention or hospitalization may be required.

The following adverse effects have been reported with losartan:

Common (may affect more than 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from blood vessels, e.g., in patients with severe heart failure or receiving high doses of diuretics),
• dose-dependent orthostatic effects such as a drop in blood pressure upon standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increased levels of blood urea, creatinine and plasma potassium in patients with heart failure.

Uncommon (may affect more than 1 in 100 people):

• drowsiness,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• chronic constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching (pruritus),
• skin rash,
• localized swelling (oedema),
• cough.

Rare (may affect more than 1 in 1,000 people):

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, Henoch-Schönlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• inflammation of the liver (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), which usually resolves upon discontinuation of treatment.

Frequency not known (cannot be estimated from available data):

• reduced number of platelets,
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• feeling of general malaise,
• ringing, buzzing, roaring or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Adverse effects in children are similar to those observed in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartán Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

High-density polyethylene (HDPE) bottle with a tamper-evident polypropylene (PP) cap.

Losartán Krka 100 mg: After first opening the container, the medicine should be used within 100 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan Krka

• The active substance is losartan potassium. Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.5 mg of losartan.
• The other components are: celactose (containing monohydrate lactose and cellulose powder), pregelatinized corn starch, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate in the tablet core; hypromellose, talc, propylene glycol and titanium dioxide (E171) in the coating. See section 2 “Losartan Krka contains lactose”.

Appearance of the product and pack contents

White, oval, convex, film-coated tablet.

Blister (PVC/PVDC//Al)

7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets in a cardboard box.

HDPE polyethylene bottle with tamper-evident polypropylene (PP) cap.

100 film-coated tablets in a cardboard box.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request further information about this medicinal product from the local representative of the Marketing Authorization Holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/